August 2004

Lack of disclosure by the pharmas puts us at risk

by Paul M. Bray

A friend called me a few weeks ago to tell me about a "scandal." He was talking about the internet data base, ClinicalTrial.gov, on which pharmaceutical and biotech companies are supposed to register all effectiveness trials of drugs for serious or life-threatening diseases. The website went online in 2000 to implement provisions in the FDA Modernization Act of 1997.

Registering of clinical trials, particularly privately funded studies, has been very spotty. In 2002, for example, the FDA found that only 48% of trials of cancer drugs had been registered. Only 13% of the studies listed on the registry are industry funded. This is at a time when government research support has declined and for profit pharmaceutical and biotech companies' share of the research has grown from 32% in 1980 to 62% in 2000.

The law is toothless without penalties or specific authority for the FDA to do enforcement. It is reported that FDA acknowledges it does not enforce the law. The registry was intended to help link patients who wanted to join trails with researchers, but runs against the desire of companies to control data, keep trade secrets from leaking out or preventing competitors from poaching on patient networks.

In fact, disclosure is only required on drug testing done on drugs before approval by FDA. Subsequent testing, for example, to determine if a drug approved to treat one disease may be effective to treat another disease, can be kept confidential.

A larger concern for disclosure of information from clinical trials came to light with a recent lawsuit by Attorney General Eliot Spitzer against GlaxoSmithKline (GSK), based in Great Britain with subsidiaries in the USA and other nations, for concealing important information about the safety and efficacy of the anti-depressant drug, Paxil.

Paxil is approved by the FDA for treatment of adult depression, but not for treatment of children. Physicians have the professional discretion to prescribe paxil for treating children, an "off-label" use.

Spitzer's lawsuit alleges that GSK withheld negative information concerning Paxil and "misrepresented data concerning Paxil's safety and efficacy when prescribed for depression in children and adolescents." It is alleged that GSK published and disseminated information on only one of five studies on the use of Paxil and suppressed the negative results of the other studies. It is also alleged in the law suit that GSK "failed to disclose this information in 'Medical Information Letters' that it sent to physicians."

In announcing this lawsuit, Spitzer said, "Doctors should have access to all scientifically sound information so that they can prescribe appropriate medication for their patients. By concealing critically important scientific studies on Paxil, GSK impaired doctors' ability to make appropriate prescribing decision for their patients and may have jeopardized their health and safety."

The failure of companies to register clinical trial information on the government website and Spitzer's investigation that included finding an internal GSK document evidencing intent to "manage the dissemination of (the) data in order to minimize any potential negative commercial impact" raises the questions of how common it is for pharmaceutical companies to withhold critical information for commercial considerations and what role the States have in doing something about it.

We are living in a time when drugs are an increasingly a part of our lives from the cradle on. I recently read that some have advocated giving babies anti-depressants. Therefore, we have to rely heavily on the conscience and ethics of the pharmaceutical industry as well as of researchers and physicians with their potential conflicts of interest that includes industry funded research and gifts from the industry. Studies have shown a link between financial support and the outcome of research studies. The NY Times pointed out a study that "linked authorship of articles discounting the dangers of passive smoking with financial ties to the tobacco industry."

Full disclosure on drugs and conflicts of interest are essential even when it has painful consequences for companies in the market place. As Drummond Rennie, a professor at the University of California and deputy editor of JAMA declared, "If I buy a camera and the thing falls apart, it's a lemon, I shrug and say I'm never going back to that firm. But if I get a drug and it makes me worse, it can kill me or maim me."

Should we wait for Congress to do something about assuring that Pharmaceutical companies are much more forthcoming in disclosing information on drugs to physicians and users? Or, should we be thankful for our Attorney General for using the courts to advance our health and welfare interests.

Commentator Marshall Manson from the Center for Individual Freedom wrote in a column in the Times Union of Albany, "Spitzer's case threatens to undermine the carefully woven fabric of regulation that ensures the quality and safety of drugs across all 50 states." He goes on to opine that "Spitzer was not elected to regulate the drug industry, and his interference with the federal government agency specifically mandated to do so constitutes a gross abuse and substantial expansion of his powers."

So much for state's rights when the conservatives have power in Washington.

The more one looks at the disclosure issue on drugs, the more troubling the situation appears. A NY Times article, "Results of Drug Trials Can Mystify Doctors Through Omission," points out a "quirk of the F.D.A.'s labeling rules may lead them to prescribe drugs for treatments that F.D.A-reviewed tests have shown to be ineffective or potentially risky."

Although recognizing the principle in support of having more information about drugs available to the public and doctors, a Washington Post editorial expresses concern that "a simple government regulation requiring publication of all results of all clinical trials might backfire and wind up discouraging companies from conducting trials at all." The Post seems to think that Congress, that gave drug companies protection from government negotiating prices for purchase of drugs with public money, can fashion incentives for disclosure on clinical trials even if "they aren't commercially advantageous." Believing that seems to me like believing in the tooth faire.

While we wait for a Congress that looks like it is fully bought and paid for the by the pharmas to put the public interest first, let us be happy that our Attorney General is making a case for our health and safety.

Paul M. Bray is President of P.M.Bray LLC, a planning and environmental law firm in Albany, New York. His e-mail is pmbray@aol.com.